Home   ->   careers   ->   Opportunities

GLP QA Senior Director

Responsibilities

• Work with the QA management to define the strategy for quality management in WuXi AppTec Co., Ltd. GLP Laboratories including process reengineering or continuous process improvement
• Support the development and implementation of a WuXi AppTec Co., Ltd. GLP-wide quality system and Quality Management System (QMS)and quality training
• Participate in the expansion of GLP principles and international laboratory quality standards (e.g. ISO) to other laboratory areas in WuXi AppTec Co., Ltd. as requested
• Participate in communication with all levels of laboratory personnel and line management on purpose, direction, and goals of quality management.
• Review and approve QA regulatory documents when required
• Conduct and report QA activities in support of BU regulatory activities, i.e., study inspections/audits, vendor audits, and facility inspections
• Assure regulatory authority inspections are fully supported
• Provide input to GLP QA Suzhou SOPs, and BU Operational SOPs
• Ensure consistent inspection practices of GLP QA operations within China
• Assume the responsibilities and role of VP GLP QA when delegated
• Monitor local projects so that work is on course to meet regulatory or client submission dates
• Oversee local QA work prioritization and resource management
• Provide local QA groups with general direction and guidance.

 

Basic Qualifications:

• Degree in Natural Sciences or Medicine or related experience
• At least 15 years  experience in medical or preclinical Research & Development
• Understanding of Quality systems and global regulatory (GLP) requirements
• Strong communication and negotiation skills
• Excellent interpersonal and leadership skills
• Excellent communication, both written and oral, in English
• Knowledge of drug development process
• Working knowledge of relevant IT systems
• Proactive compliance philosophy
• Significant prior experience in GLP QA
 

Any applications, pls contact: lu_lijun@wuxiapptec.com; global_talent@wuxiapptec.com